510(k) · Cleared
ClearedSingle Use Hand Switch Monopolar Forceps with Smoke Evacuation, Single Use Hand Switch Bipolar Forceps with Smoke Evacuation, Single Use Hand Switch Monopolar Forceps, Single Use Hand Switch Bipolar Forceps
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Modern Medical Equipment Manufacturing, Ltd. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Mar 17, 2022 as substantially equivalent to K130669 (Olsen Medical, 2013) and 2 other predicates after a 407-day review. Its family tree reaches back 8 generations to 1992.
- Decided
- Mar 17, 2022
- Review
- 407 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 8 generations to K923332 (1992). 19 ancestors in all, the oldest K884656 (1988). No later device cites it as a predicate yet.
- Root · 8 generations backK923332 Electrosurgical ElectrodesPremier Dental Products Co. · 1992
- 7 generations backK970987 Electrosurgical ElectrodeFusion Medical Technologies, Inc. · 1997
- 6 generations backK992931 Non-Stick Bipolar ForcepsSilverglide Surgical Technologies · 1999
- 5 generations backK051429 Claris Non-Stick Bipolar ForcepsGuenter Bissinger Medizintechnik GmbH · 2005
- 4 generations backK070997 Doro Non-Stick Bipolar Forceps, Model 5001-XX to 5012-XX, Doro…Pro-Med Instruments GmbH · 2007
- 3 generations backK083162 Stingray Electrosurgical ForcepsStingray Surgical Products, Inc. · 2009 · Recalled
- 2 generations backK093108 Stryker Bipolar ForcepsStryker Leibinger GmbH & Co KG · 2010
- 1 generation backK130669 Single Use & Multi Use Bipolar Forceps / Single Use & Multi Use…Olsen Medical · 2013 · Recalled
- This deviceK210315 Single Use Hand Switch Monopolar Forceps with Smoke Evacuation…Modern Medical Equipment Manufacturing, Ltd. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K923332 | Electrosurgical Electrodes | Premier Dental Products Co. | 1992 | — |
| −7 | K970987 | Electrosurgical Electrode | Fusion Medical Technologies, Inc. | 1997 | — |
| −6 | K992931 | Non-Stick Bipolar Forceps | Silverglide Surgical Technologies | 1999 | — |
| −5 | K051429 | Claris Non-Stick Bipolar Forceps | Guenter Bissinger Medizintechnik GmbH | 2005 | — |
| −4 | K070997 | Doro Non-Stick Bipolar Forceps, Model 5001-XX to 5012-XX, Doro Bipolar… | Pro-Med Instruments GmbH | 2007 | — |
| −3 | K083162 | Stingray Electrosurgical Forceps | Stingray Surgical Products, Inc. | 2009 | 1 |
| −2 | K093108 | Stryker Bipolar Forceps | Stryker Leibinger GmbH & Co KG | 2010 | — |
| −1 | K130669 | Single Use & Multi Use Bipolar Forceps / Single Use & Multi Use Monopolar… | Olsen Medical | 2013 | 1 |
| 0 (this device) | K210315 | Single Use Hand Switch Monopolar Forceps with Smoke Evacuation, Single Use… | Modern Medical Equipment Manufacturing, Ltd. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2004 | 1 | 0 |
| 2011 | 1 | 0 |
| 2020 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GEI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new GEI device
- #1 K231790 The InMode System with the Morpheus8 Applicatorsscore 32.7 · 21 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K130669 | Single Use & Multi Use Bipolar Forceps / Single Use & Multi Use Monopolar ForcepsSummary page 4…s: II 3. Predicate device 3.1 Olsen Medical SINGLE USE & MULTI USE BIPOLAR FORCEPS / SINGLE USE & MULTI USE MONOPOLAR FORCEPS with 510(k) number K130669, cleared Dec 06,2013. 510(k) Summary-K210315 Page 2 of 15 3.2… | 2013 |
| * | K200372 | Smoke Evacuation Fingerswitch, Smoke evacuation system with electrosurgical pencilSummary page 5…Page 2 of 15 3.2 Modern Medical Smoke Evacuation Fingerswitch, Smoke Evacuation System With Electrosurgical Pencil with 510(k) number K200372, cleared Nov 30, 2020. 3.3 Modern Medical Bipolar Forceps with 510(k) number K032327 4. Device description Modern Medical… | 2020 |
| * | K032327 | Modern Medical Bipolar ForcepsSummary page 5…ingerswitch, Smoke Evacuation System With Electrosurgical Pencil with 510(k) number K200372, cleared Nov 30, 2020. 3.3 Modern Medical Bipolar Forceps with 510(k) number K032327 4. Device description Modern Medical Electrosurgical Monopolar Forceps and Bipolar Forceps have been designed as active… | 2004 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 30 years and passes through 9 companies; a new generation was cleared every 3.5 years on median.
- 5 of the 19 ancestors have a recall of any class.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · GEI
52in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEI
113in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEI
4in 2025
Class I (14 since 2007) Class II/III not classified
Adverse event reports per year · GEI
7,592in 2025
MAUDE reports naming product code GEI, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 50 | 51 | 21 | 2,795 |
| 2008 | 61 | 71 | 19 | 2,556 |
| 2009 | 42 | 130 | 27 | 3,591 |
| 2010 | 46 | 109 | 51 | 3,377 |
| 2011 | 35 | 135 | 32 | 4,463 |
| 2012 | 39 | 133 | 30 | 5,216 |
| 2013 | 48 | 136 | 13 | 4,897 |
| 2014 | 49 | 103 | 3 | 4,908 |
| 2015 | 47 | 123 | 4 | 4,936 |
| 2016 | 64 | 108 | 3 | 5,616 |
| 2017 | 52 | 72 | 2 | 6,073 |
| 2018 | 47 | 93 | 6 | 6,545 |
| 2019 | 48 | 93 | 5 | 7,067 |
| 2020 | 59 | 105 | 1 | 6,490 |
| 2021 | 46 | 146 | 6 | 6,354 |
| 2022 | 55 | 150 | 49 | 6,103 |
| 2023 | 65 | 104 | 27 (4) | 7,176 |
| 2024 | 59 | 125 | 22 (10) | 7,897 |
| 2025 | 52 | 113 | 4 | 7,592 |
| 2026 | 43 | 183 | 8 | — |
What is it indicated for?
1. Single Use Hand Switch Monopolar Forceps with Smoke Evacuation (CD954) The device delivers electrosurgical current to target tissue for coagulation in electrosurgical procedure, with the additional function to facilitate the removal of surgical smoke generated by electrosurgery. 2. Single Use Hand Switch Bipolar Forceps with Smoke Evacuation (CD955) The device delivers electrosurgical current to target tissue for coagulation in electrosurgical…
Read the full statement (118 words)
1. Single Use Hand Switch Monopolar Forceps with Smoke Evacuation (CD954)
The device delivers electrosurgical current to target tissue for coagulation in electrosurgical procedure, with the additional function to facilitate the removal of surgical smoke generated by electrosurgery.
2. Single Use Hand Switch Bipolar Forceps with Smoke Evacuation (CD955)
The device delivers electrosurgical current to target tissue for coagulation in electrosurgical procedure, with the additional function to facilitate the removal of surgical smoke generated by electrosurgery.
3. Single Use Hand Switch Monopolar Forceps (CD956)
The device delivers electrosurgical current to target tissue for coagulation in electrosurgical procedure.
4. Single Use Hand Switch Bipolar Forceps (CD957)
The device delivers electrosurgical current to target tissue for coagulation in electrosurgical procedure.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K210315 · printed Nov 6, 2026
Cite this page
510(k) Report. “K210315: Single Use Hand Switch Monopolar Forceps with Smoke Evacuation, Single Use Hand Switch Bipolar Forceps with Smoke Evacuation, Single Use Hand Switch Monopolar Forceps, Single Use Hand Switch Bipolar Forceps.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K210315
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026